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Introduction: People living with type 2 diabetes who experience homelessness face a myriad of barriers to engaging in diabetes self-care behaviors that lead to premature complications and death. This is exacerbated by high rates of comorbid mental illness, substance use disorder, and other physical health problems. Despite strong evidence to support lay health coach and behavioral activation, little research has effectively engaged people living with type 2 diabetes who had experienced homelessness (DH). Methods: We used community engaged research and incremental behavioral treatment development to design the Diabetes HOmeless MEdication Support (D-HOMES) program, a one-on-one, 3 month, coaching intervention to improve medication adherence and psychological wellness for DH. We present results of our pilot randomized trial (with baseline, 3 mo., 6 mo. assessments) comparing D-HOMES to enhanced usual care (EUC; brief diabetes education session and routine care; NCT05258630). Participants were English-speaking adults with type 2 diabetes, current/recent (<24 mo.) homelessness, and an HbA1c_7.5%. We focused on feasibility (recruitment, retention, engagement) and acceptability (Client Satisfaction Questionnaire, CSQ-8). Our primary clinical outcome was glycemic control (HbA1c) and primary behavioral outcome was medication adherence. Secondary outcomes included psychological wellness and diabetes self-care. Results: Thirty-six eligible participants enrolled, 18 in each arm. Most participants identified as Black males, had high rates of co-morbidities, and lived in subsidized housing. We retained 100% of participants at 3-months, and 94% at 6-months. Participants reported high satisfaction (mean CSQ-8 scores=28.64 [SD 3.94] of 32). HbA1c reduced to clinically significant levels in both groups, but we found no between group differences. Mean blood pressure improved more in D-HOMES than EUC between baseline and 6 mo. with between group mean differences of systolic -19.5 mmHg (p=0.030) and diastolic blood pressure -11.1 mmHg (p=0.049). We found no significant between group differences in other secondary outcomes. Conclusion: We effectively recruited and retained DH over 6 months. Data support that the D-HOMES intervention was acceptable and feasible. We observe preliminary blood pressure improvement favoring D-HOMES that were statistically and clinically significant. D-HOMES warrants testing in a fully powered trial which could inform future high quality behavioral trials to promote health equity. Clinical trial registration: https://clinicaltrials.gov/study/NCT05258630?term=D-HOMES&rank=1, identifier NCT05258630.
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Introduction: Compared to stably housed peers, people experiencing homelessness (PEH) have lower rates of ideal glycemic control, and experience premature morbidity and mortality. High rates of behavioral health comorbidities and trauma add to access barriers driving poor outcomes. Limited evidence guides behavioral approaches to support the needs of PEH with diabetes. Lay coaching models can improve care for low-resource populations with diabetes, yet we found no evidence of programs specifically tailored to the needs of PEH. Methods: We used a multistep, iterative process following the ORBIT model to develop the Diabetes Homeless Medication Support (D-HOMES) program, a new lifestyle intervention for PEH with type 2 diabetes. We built a community-engaged research team who participated in all of the following steps of treatment development: (1) initial treatment conceptualization drawing from evidence-based programs, (2) qualitative interviews with affected people and multi-disciplinary housing and healthcare providers, and (3) an open trial of D-HOMES to evaluate acceptability (Client Satisfaction Questionnaire, exit interview) and treatment engagement (completion rate of up to 10 offered coaching sessions). Results: In step (1), the D-HOMES treatment manual drew from existing behavioral activation and lay health coach programs for diabetes as well as clinical resources from Health Care for the Homeless. Step (2) qualitative interviews (n = 26 patients, n = 21 providers) shaped counseling approaches, language and choices regarding interventionists, tools, and resources. PTSD symptoms were reported in 69% of patients. Step (3) trial participants (N = 10) overall found the program acceptable, however, we saw better program satisfaction and treatment engagement among more stably housed people. We developed adapted treatment materials for the target population and refined recruitment/retention strategies and trial procedures sensitive to prevalent discrimination and racism to better retain people of color and those with less stable housing. Discussion: The research team has used these findings to inform an NIH-funded randomized control pilot trial. We found synergy between community-engaged research and the ORBIT model of behavioral treatment development to develop a new intervention designed for PEH with type 2 diabetes and address health equity gaps in people who have experienced trauma. We conclude that more work and different approaches are needed to address the needs of participants with the least stable housing.
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Importance: Tobacco use prevalence among individuals involved in the criminal-legal system is 125% higher than that of the general population and leads to high levels of smoking-related morbidity and mortality. Objective: To examine the acceptability, feasibility, and preliminary clinical outcomes of a smoking cessation intervention for individuals who are incarcerated. Design, Setting, and Participants: This pilot randomized clinical trial was conducted from January 2019 to May 2020. Participants were recruited in a pretrial county jail in a large Midwestern US city and were followed up after release. Participants were incarcerated, smoked daily before incarceration, desired to stay quit or reduce cigarette smoking upon release, and expected to be released to the community within 90 days of enrollment. Data analysis was performed from June to October 2020. Interventions: Participants randomized to the counseling plus nicotine replacement therapy (NRT) group received 1 hour of smoking cessation counseling in jail, a supply of nicotine lozenges upon release, and up to 4 telephone counseling sessions after release. Those randomized to brief health education (BHE) received 30 minutes of general health education in jail. Main Outcomes and Measures: The primary clinical outcome was biologically verified 7-day point prevalence abstinence (PPA) at 3 weeks after release. Secondary clinical outcomes included 7-day PPA at 12 weeks, changes in number of cigarettes per day, and time to smoking lapse and relapse. Results: A total of 46 participants (42 men [91%]; mean [SD] age, 38.2 [9.1] years) were enrolled and remained eligible at release; 23 were randomized to the counseling plus NRT group and 23 were randomized to the BHE group. Recruitment, enrollment, and retention of participants was feasible and acceptable. There were no significant differences in smoking abstinence between groups as determined by 7-day PPA at 3 weeks (adjusted 7-day PPA, 11.9% for counseling plus NRT vs 10.6% for BHE; odds ratio, 1.13; 95% CI, 0.14-9.07) and at 12 weeks (adjusted 7-day PPA, 11.1% for counseling plus NRT vs 14.3% for BHE; odds ratio, 0.75; 95% CI, 0.09-6.11). Cigarettes per day for the counseling plus NRT group decreased more compared with the BHE group at both 3 weeks (difference [SE], -4.58 [1.58] cigarettes per day; 95% CI, -7.67 to -1.48 cigarettes per day; P = .007) and 12 weeks (difference [SE], -3.26 [1.58] cigarettes per day; 95% CI, -5.20 to -0.20 cigarettes per day; P = .04) after release. Conclusions and Relevance: Initiation of counseling plus NRT during incarceration and continuing after release is feasible and acceptable to participants and may be associated with reduced cigarette use after release. However, additional supports are needed to increase engagement in telephone counseling after release. A larger clinical trial is warranted to determine the effectiveness of counseling plus NRT. Trial Registration: ClinicalTrials.gov Identifier: NCT03799315.